Olmesartan/hydrochlorothiazide Combix 40 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartán/Hidroclorotiazida Combix 40 mg/12.5 mg film-coated tablets EFG

Olmesartan medoxomil/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Olmesartán/Hidroclorotiazida Combix is and what it is used for
2. What you need to know before taking Olmesartán/Hidroclorotiazida Combix
3. How to take Olmesartán/Hidroclorotiazida Combix
4. Possible side effects
5. How to store Olmesartán/Hidroclorotiazida Combix

Pack contents and other information

1. What Olmesartán/Hidroclorotiazida Combix is and what it is used for

Olmesartán/Hidroclorotiazida Combix contains two active substances, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

• Olmesartán medoxomilo belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

You will only be given Olmesartán/Hidroclorotiazida Combix if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartán/Hidroclorotiazida Combix helps reduce blood pressure more than either substance alone.

You may already be taking medicines to treat high blood pressure, but your doctor may consider it necessary for you to take Olmesartán/Hidroclorotiazida Combix to lower it further.

High blood pressure can be controlled with medicines such as Olmesartán/Hidroclorotiazida Combix tablets. Your doctor may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing salt intake). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmesartán/Hidroclorotiazida Combix

Do not take Olmesartán/Hidroclorotiazida Combix

• if you are allergic to olmesartan medoxomil, hydrochlorothiazide, any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• if you are more than 3 months pregnant. (It is also advisable to avoid Olmesartán/Hidroclorotiazida Combix in early pregnancy – see Pregnancy section).
• if you have kidney problems.
• if you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• if you have moderate or severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of these apply to you, or you are unsure, do not take the tablets. Speak to your doctor and follow their advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking Olmesartán/Hidroclorotiazida Combix:

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren

• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to one week after taking Olmesartán/Hidroclorotiazida Combix.

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Olmesartán/Hidroclorotiazida Combix.

• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmesartán/Hidroclorotiazida Combix, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/hydrochlorothiazide monotherapy without medical advice.

See also the information under the heading “Do not take Olmesartán/Hidroclorotiazida Combix”.

Before taking the tablets, tell your doctor if you have any of the following health conditions:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (with dizziness) or diarrhea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

Contact your doctor if you develop severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Your doctor may want to see you more frequently and perform some tests if you have any of these conditions.

Olmesartán/Hidroclorotiazida Combix may cause increased levels of lipids and uric acid (which causes gout – painful swelling of the joints) in the blood. Your doctor may want to perform periodic blood tests to monitor these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may perform periodic blood tests to monitor this possible effect. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, fatigued, drowsy, restless, vomiting, reduced need to urinate, or rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should stop taking Olmesartán/Hidroclorotiazida Combix before the tests are performed.

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

Inform your doctor if you are pregnant or think you might be pregnant. Use of Olmesartán/Hidroclorotiazida Combix is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if taken during this stage (see Pregnancy section).

Children and adolescents

Olmesartán/Hidroclorotiazida Combix is not recommended for children and adolescents under 18 years of age.

Taking Olmesartán/Hidroclorotiazida Combix with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Olmesartán/Hidroclorotiazida Combix” and “Warnings and precautions”).

In particular, inform your doctor or pharmacist about any of the following medicines:

• Medicines that may alter potassium levels in the blood when used together with Olmesartán/Hidroclorotiazida Combix. These include:
• Potassium supplements (as well as salt substitutes containing potassium).
• Medicines that increase urine elimination (diuretics).
• Heparin (a blood thinner).
• Laxatives.
• Steroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).
• Some painkillers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used with Olmesartán/Hidroclorotiazida Combix. If you must take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with Olmesartán/Hidroclorotiazida Combix, may increase the risk of kidney failure and reduce the effect of Olmesartán/Hidroclorotiazida Combix.
• Other blood pressure-lowering medicines (antihypertensives), as they may enhance the effect of Olmesartán/Hidroclorotiazida Combix.
• Sleeping pills, sedatives, and antidepressants, which when used with Olmesartán/Hidroclorotiazida Combix may cause a sudden drop in blood pressure upon standing.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Anticholinergic medicines such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain heart medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.
• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, since Olmesartán/Hidroclorotiazida Combix may intensify their blood sugar-raising effect.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.
• Difemanyl, used to treat slow heartbeat or reduce sweating.
• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Tetracycline antibiotics or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Some antacids used to treat excess stomach acid, such as aluminum and magnesium hydroxide, which may slightly reduce the effect of Olmesartán/Hidroclorotiazida Combix.
• Cisapride, used to increase gastrointestinal motility.
• Halofantrine, used to treat malaria.

Taking Olmesartán/Hidroclorotiazida Combix with food, drinks, and alcohol

Olmesartán/Hidroclorotiazida Combix can be taken with or without food.

Be cautious when drinking alcohol while taking Olmesartán/Hidroclorotiazida Combix, as some people may feel weak or dizzy. If this happens, avoid alcohol, including wine, beer, or alcoholic beverages.

Patients of Black ethnicity

As with other similar medicines, the blood pressure-lowering effect of Olmesartán/Hidroclorotiazida Combix is somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Olmesartán/Hidroclorotiazida Combix before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Olmesartán/Hidroclorotiazida Combix is not recommended during pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartán/Hidroclorotiazida Combix is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

Use in athletes

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

Driving and using machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartán/Hidroclorotiazida Combix contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Olmesartán/Hidroclorotiazida Combix

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida 40 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida 40 mg/25 mg daily.

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. It is important that you continue taking Olmesartán/Hidroclorotiazida as long as your doctor has instructed you to do so.

If you take more Olmesartán/Hidroclorotiazida Combix than you should

If you take more tablets than prescribed or if a child accidentally swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and bring the medicine package with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Olmesartán/Hidroclorotiazida Combix

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Olmesartán/Hidroclorotiazida Combix

It is important to continue taking Olmesartán/Hidroclorotiazida unless your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions may occur that can affect the entire body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide and consult your doctor immediately.
• In sensitive individuals or as a result of an allergic reaction, Olmesartan/Hydrochlorothiazide may cause blood pressure to drop too low. Fainting or dizziness may occur infrequently. If this happens, stop taking Olmesartan/Hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.
• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have just started treatment with Olmesartan/Hydrochlorothiazide, contact your doctor immediately, who will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/Hydrochlorothiazide is a combination of two active substances. The following information first describes the adverse effects reported so far with the combination Olmesartan/Hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of the two active substances taken separately.

These are other known adverse effects reported so far with Olmesartan/Hydrochlorothiazide.

If these effects occur, they are often mild and you do not need to stop treatment.

Common adverse effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid and strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arms and legs pain, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, the following changes in blood test results have also been observed:

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood sugar, increase in liver function test values. Your doctor will monitor you with a blood test and will advise you whether any action is needed.

Rare adverse effects (may affect up to 1 in 1,000 people):

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute renal failure.

Rarely, the following changes in blood test results have also been observed:

Increase in blood urea nitrogen, decrease in hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and will advise you whether any action is needed.

Additional adverse effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartan/Hydrochlorothiazide, or at a higher frequency:

Olmesartan medoxomil

Common adverse effects (may affect up to 1 in 10 people):

Bronchitis, cough, nasal congestion and discharge, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Frequently observed changes in blood test results include:

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test levels.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid allergic reactions that may affect the entire body and may cause breathing difficulties, as well as a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Uncommonly, the following changes in blood test results have also been observed:

Reduction in the number of a type of blood cells called platelets (thrombocytopenia).

Rare adverse effects (may affect up to 1 in 1,000 people):

Worsening of kidney function, lack of energy, pruritus.

Rarely, the following changes in blood test results have also been observed:

Increase in blood potassium levels.

Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Hydrochlorothiazide

Very common adverse effects (may affect more than 1 in 10 people):

Changes in blood tests including: increase in blood fat levels and blood uric acid levels.

Common adverse effects (may affect up to 1 in 10 people):

Feeling confused, abdominal pain, stomach discomfort, bloated feeling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Changes in blood test results include:

Increase in creatinine, urea, calcium, and blood sugar levels; decrease in blood levels of chloride, potassium, magnesium, and sodium. Increase in serum amylase (hyperamylasemia).

Uncommon adverse effects (may affect up to 1 in 100 people):

Decreased or loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or patches on the skin due to small hemorrhages (purpura), skin swelling (hives).

Rare adverse effects (may affect up to 1 in 1,000 people):

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellow vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus (such as skin rash, joint pain, and coldness in hands and fingers), skin allergic reactions, skin peeling and blisters, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (which may sometimes cause movement disturbances).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance which may cause abnormally low levels of chloride in blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known:

Skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Combix

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and on the blister after “EXP.:”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Combix

• The active substances are olmesartan medoxomil and hydrochlorothiazide.

Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

• The other components are lactose monohydrate, microcrystalline cellulose (E460i), low-substituted hydroxypropylcellulose (E463), hydroxypropylcellulose (E463), stearic acid (E570), magnesium stearate (E470b), and Instacoat Universal Yellow A05R01290 composed of: hypromellose (E464), polyethylene glycol (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Olmesartan/Hydrochlorothiazide Combix 40 mg/12.5 mg is presented as orange, oval, biconvex, film-coated tablets, engraved with the number "4" on one side and smooth on the other.

The tablets are supplied in Alu/Alu blister packs with desiccant.

The following pack sizes are available: 28 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

Zac Les Hautes Pâtures

Parc d'Activités des Pleupliers

25 rue des Pleupliers

92000 Nanterre

France

or

Netpharmalab Consulting Services

Crta. de Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.